Safety assessment of FDA-approved (orlistat and lorcaserin) anti-obesity medications

Bibliography

• Rosen ED, Spiegelman BM. What we talk about when we talk about fat. Cell 2014;156(1-2):20-44
   PubMed Web of Science ®Google Scholar
• Brownell KD, Wadden TA. Etiology and treatment of obesity: understanding a serious, prevalent and refractory disorder. J Consult Psychol 1992;60(4):505-17
   Google Scholar
• Morton GJ, Meek TH, Schwarts MW. Neurobiology of food intake in health and disease. Nat Rev Neurosci 2014;15(6):367-78
   PubMed Web of Science ®Google Scholar
• Virtue S, Vidal-Puig A. It´s not how fat we are, it´s what you do with it that counts. PLoS Biol 2008;6(9):e237
   PubMed Web of Science ®Google Scholar
• Reuser M, Bonneux LG, Willekens FJ. Smoking kills, obesity disables: a multistate approach of the US health and retirement survey. Obesity (Silver Spring) 2009;17(4):783-9
   PubMed Web of Science ®Google Scholar
• Allison DB, Fontaine KR, Manson JE, et al. Annual deaths attributable to obesity in the united states. JAMA 1999;282(16):1530-8
   PubMed Web of Science ®Google Scholar
• Pischon T, Boeing H, Hoffmann K, et al. General and abdominal adiposity and risk of death in europe. N Engl J Med 2008;359(20):2105-20
   PubMed Web of Science ®Google Scholar
• Flegal KM, Graubard BI, Williamson DF, et al. Cause specific excess deaths associated with underweight, overweight and obesity. JAMA 2007;298(17):2028-37
   PubMed Web of Science ®Google Scholar
• Calle EE, Rodriguez C, Walker Thurmond B, et al. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Eng J Med 2003;348(17):1625-38
   PubMed Web of Science ®Google Scholar
• Global strategy on diet, physical activity and health. World Health Organization, Geneva, Switzerland. 2010. Available from: http://www.who.int/dietphysicalactivity/publications/facts/obesity/en/print.html/
   Google Scholar
• Dansinger ML, Tatsioni A, Wong JB, et al. Meta-analysis: the effect of dietary counseling for weight loss. Ann Intern Med 2007;3147(1):41-50
   Web of Science ®Google Scholar
• Leblanc ES, O´Connor E, Whitlock EP, et al. Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the US preventive services task force. Ann Intern Med 2011;155(7):434-47
   PubMed Web of Science ®Google Scholar
• Wadden TA, Volger S, Sarwer DB, et al. A 2-year randomized trial of obesity treatment in primary care practice. N Engl J Med 2011;365(21):1969-79
   PubMed Web of Science ®Google Scholar
• Colman E. FDA´s obesity drug guidance document: a short history. Circulation 2012;125(17):2156-64
   PubMed Web of Science ®Google Scholar
• Curfman GD, Morrissey S, Drazen JM. Sibutramine - Another flawed pill. N Engl J Med 2010;363(10):972-4
   PubMed Web of Science ®Google Scholar
• Colman E, Golden J, Roberts M, et al. The FDA´s assessment of two drugs for chronic weight management. N Engl J Med 2012;367(17):1577-9
   PubMed Web of Science ®Google Scholar
• Li MF, Cheung BM. Rise and fall of anti-obesity drugs. World J Diabetes 2011;2(2):19-23
   PubMedGoogle Scholar
• Astrup A. Drug management of obesity–efficacy versus safety. N Engl J Med 2010;363(3):288-90
   PubMed Web of Science ®Google Scholar
• European medicines agency. Withdrawal of the marketing authorisation application for belviq (lorcaserin) (EMA/309180/2013). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2013/05/WC500143811.pdf [Accessed 12 August 2014]
   Google Scholar
• European medicines agency. Refusal of the marketing authorisation for qsymia (phentermine/topiramate). Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002350/human_med_001607.jsp&mid=WC0b01ac058001d124 [Accessed 12 August 2014]
   Google Scholar
• Borgström B. Mode of action of tetrahydrolipstatin: a derivative of the naturally occurring lipase inhibitor lipstatin. Bioch Biophys Acta 1988;962(3):308-16
   PubMed Web of Science ®Google Scholar
• Zhi J, Melia AT, Eggers H, et al. Review of limited systemic absortion of orlistat, a lipase inhibitor, in healthy human volunteers. J Clin Pharmacol 1995;35(11):1103-8
   PubMed Web of Science ®Google Scholar
• Ballinger A, Peikin SR. Orlistat: its current status as an anti-obesity drug. Eur J Pharmacol 2002;440(2-3):109-17
   PubMed Web of Science ®Google Scholar
• Anderson JW. Orlistat for the management of overweight individuals and obesity: a review of potential for the 60-mg, over-the-counter dosage. Expert Opin Pharmacother 2007;8(11):1733-42
   PubMed Web of Science ®Google Scholar
• Mancini MC, Halpern A. Orlistat in the prevention of diabetes in the obese patient. Vasc Health and Risk Manag 2008;4:325-36
   PubMedGoogle Scholar
• Rucker D, Padwal R, Li SK, et al. Long term pharmacotherapy for obesity and overweight: updated meta-analysis. BMJ 2007;335(7631):1194-9
   PubMed Web of Science ®Google Scholar
• Zavoral JH. Treatment with orlistat reduces cardiovascular risk in obese patients. J Hypertension 1998;16(12 Pt 2):2013-17
   PubMed Web of Science ®Google Scholar
• Bakris G, Calhoun D, Egan B, et al. Orlistat improves blood pressure control in obese subjects with treated but inadequately controlled hypertension. J Hypertens 2002;20(11):2257-67
   PubMed Web of Science ®Google Scholar
• Torgerson JS, Hauptamn J, Boldrin MN, et al. XENical in the prevention of diabetes in obese subjects (XENDOS) Study. Diabetes Care 2004;27(1):155-61
   PubMed Web of Science ®Google Scholar
• Halpern A, Mancini MC, Suplicy H, et al. Latin-American trial of orlistat for weight loss and improvement in glycaemic profile in obese diabetic patients. Diabetes Obes Metab 2003;5(3):180-8
   PubMed Web of Science ®Google Scholar
• Swinburn BA, Carey D, Hills AP, et al. Effects of orlistat on cardiovascular disease risk in obese adults. Diabetes Obes Metab 2005;7(3):254-62
   PubMed Web of Science ®Google Scholar
• Hussein O, Grosovski M, Schlesinger S, et al. Orlistat reverse fatty infiltration and improves hepatic fibrosis in obese patients with nonalcoholic steatohepatits (NASH). Dig Dis Sci 2007;52(10):2512-19
   PubMed Web of Science ®Google Scholar
• Harp JB. An assessment of the efficacy and safety of orlistat for the long-term management of obesity. J Nutr Biochem 1998;9(9):516-21
   Web of Science ®Google Scholar
• Filipattos TD, Derdemezis CS, Gazi IF, et al. Orlistat-associated adverse effects and drug interactions. A critical review. Drugs Safety 2008;31(1):53-65
   PubMed Web of Science ®Google Scholar
• McDuffie JR, Calis KA, Booth SL, et al. Effects of orlistat on fat-soluble vitamins in obese adolescents. Pharmacotherapy 2002;22(7):814-22
   PubMed Web of Science ®Google Scholar
• Melia AT, Koss-Twardy SG, Zhi J. The effect of orlistat, an inhibitor of dietary fat absortion, on the absortion of vitamins A and E in healthy volunteers. J Clin Pharmacol 1996;36(7):647-53
   PubMed Web of Science ®Google Scholar
• Via M. The malnutrition of obesity: micronutrients deficiencies that promote diabetes. ISRN Endocrinol 2012;2012:103472
   PubMedGoogle Scholar
• García OP, Long KZ, Rosado JL. Impact of micronutrient deficiencies on obesity. Nutr Rev 2009;67(10):559-72
   PubMed Web of Science ®Google Scholar
• Zhi J, Melia AT, Guerciolini R, et al. The effect of orlistat on the pharmacodynamics of warfarin in healthy volunteers. J Clin Pharmacol 1996;36(7):659-66
   PubMed Web of Science ®Google Scholar
• MacWalter RS, Fraser HW, Armstrong KM. Orlistat enhances warfarin effect. Ann Pharmacother 2003;37(4):510-12
   PubMed Web of Science ®Google Scholar
• Ferraz RR, Tiselius HG, Heilberg IP. Fat malabsorption induced by gastrointestinal lipase inhibitor leads to an increase in urinary oxalate excretion. Kidney Int 2004;66(2):676-82
   PubMed Web of Science ®Google Scholar
• Singh A, Sarkar SR, Gaber LW, et al. Acute oxalate nephropathy associated with orlistat, a gastrointestinal lipase inhibitor. Am J Kidney Dis 2007;49(1):153-7
   PubMed Web of Science ®Google Scholar
• Courtney AE, O’Rourke DM, Maxwell AP. Rapidly progressive renal failure associated with successful pharmacotherapy for obesity. Nephrol Dial Transplant 2007;22(2):621-3
   PubMed Web of Science ®Google Scholar
• Chaudhari D, Crisostomo C, Ganote C, et al. Acute oxalate nephropathy associated with orlistat: a case report with a review of the literature. Case Rep Nephrol 2013;2013:124604
   PubMedGoogle Scholar
• Karamadoukis L, Shivashankar GH, Ludeman L, et al. An unusual complication of treatment with orlistat. Clin Nephrol 2009;71(4):430-2
   PubMed Web of Science ®Google Scholar
• Weir MA, Beyea MM, Gomes T, et al. Orlistat and acute kidney injury: an analysis of 953 patients. Arch Intern Med 2011;171(7):703-4
   PubMed Web of Science ®Google Scholar
• Pace DG, Blotner S, Guerciolini R. Short-term orlistat treatment does not affect mineral balance and bone turnover in obese men. J Nutr 2001;131(6):1694-9
   PubMed Web of Science ®Google Scholar
• Zhi J, Moore R, Kanitra L. The effect of short-term (21-day) orlistat treatment on the physiologic balance of six selected macrominerals and microminerals in obese adolescents. J Am Coll Nutr 2003;22(5):357-62
   PubMed Web of Science ®Google Scholar
• Gotfredsen A, Westergren Hendel H, et al. Influence of orlistat on bone turnover and body composition. Int J Obes Relat Metab Disord 2001;25(8):1154-60
   PubMed Web of Science ®Google Scholar
• Le Beller C, Bezie Y, Chabatte C, et al. Co-administration of orlistat and cyclosporine in a heart transplant recipient. Transplantation 2000;70(10):1541-2
   PubMed Web of Science ®Google Scholar
• Evans S, Michael R, Wells H, et al. Drug interaction in a renal transplant patient: cyclosporine-neoral and orlistat. Am J Kidney Dis 2003;41(2):493-6
   PubMed Web of Science ®Google Scholar
• Barbaro D, Orsini P, Pallini S, et al. Obesity in transplant patients: case report showing interference of orlistat with absorption of cyclosporine and review of literature. Endocr Pract 2002;8(2):124-6
   PubMedGoogle Scholar
• FDA. Orlistat (marketed as Alli and Xenical): early communication about an ongoing safety review. FDA, 2009. 2012. Available from: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180025.htm
   Google Scholar
• Morris M, Lane P, Lee K, et al. An integrated analysis of liver safety data from orlistat clinical trials. Obes Facts 2012;5(4):485-94
   PubMed Web of Science ®Google Scholar
• Umemura T, Ichijo T, Matsumoto A, et al. Severe hepatic injury caused by orlistat. Am J Med 2006;119(8):e7
   PubMed Web of Science ®Google Scholar
• Thuraijarah PH, Syn WK, Neil DA, et al. Orlistat (Xenical)-induced subacute liver failure. Eur J Gastroenterol Hepatol 2005;17(12):1437-8
   PubMed Web of Science ®Google Scholar
• Montero JL, Muntané J, Fraga E, et al. Orlistat associated subacute hepatic failure. J Hepatol 2001;34(1):173
   PubMed Web of Science ®Google Scholar
• Douglas IJ, Langham J, Bhaskaran K, et al. Orlistat and the risk of acute liver injury: self controlled case series study in UK clinical practice research datalink. BMJ 2013;346:f1936
   PubMed Web of Science ®Google Scholar
• Ahnen DJ, Guercioloni R, Hauptman J, et al. Effect of orlistat on fecal fat, fecal biliary acids, and colonic cell proliferation in obese subjects. Clin Gastroenterol Hepatol 2007;5(11):1291-9
   PubMed Web of Science ®Google Scholar
• Pickering JS, Lupton JR, Chapkin RS. Dietary fat, fiber and carcinogen alter fecal diacylglycerol composition and mass. Cancer Res 1995;55(11):2293-8
   PubMed Web of Science ®Google Scholar
• Newmark HL, Wargovich MJ, Bruce WR. Colon cancer and dietary fat, phosphate and calcium: a hypothesis. J Natl Cancer Inst 1984;72(6):1323-5
   PubMed Web of Science ®Google Scholar
• Giovannucci E, Willett WC. Dietary factors and risk of colon cancer. Ann Med 1994;26(6):443-52
   PubMed Web of Science ®Google Scholar
• Potter JD. Nutrition and colorectal cancer. Cancer Causes Control 1996;7(1):127-46
   PubMed Web of Science ®Google Scholar
• Garcia SB, Barros LT, Turatti A, et al. The anti-obesity agent orlistat is associated to increase in colonic preneoplastic markers in rats treated with a chemical carcinogen. Cancer Lett 2006;240(2):221-4
   PubMed Web of Science ®Google Scholar
• Orlistat (Zenical®) preclinical and clinical summary report on colon cancer. 2006. Available from: www.fda.gov/ohrms/dockets/dockets/06p0154/06p-0154-c000002-04-Attachment-02-vol3.pdf
   Google Scholar
• Hong JL, Meier CR, Sandler RS, et al. Risk of colorectal cancer after initiation of orlistat: matched cohort study. BMJ 2013;347:f5039
   PubMed Web of Science ®Google Scholar
• Samudio I, Harmancey R, Fiegl M, et al. Pharmacologic inhibition of fatty acid oxidation sensitizes human leukemia cells to apoptosis induction. J Clin Invest 2010;120(1):142-56
   PubMed Web of Science ®Google Scholar
• Sounni NE, Cimino J, Blacher S, et al. Blocking lipid synthesis overcomes tumor regrowth and metastasis after antiangiogenic therapy withdrawal. Cell Metab 2014;20(2):280-94
   PubMed Web of Science ®Google Scholar
• Agostini M, Almeida LY, Bastos DC, et al. The fatty acid synthase inhibitor orlistat reduces the growth and metastasis of orthotopic tongue oral squamous cell carcinomas. Mol Cancer Ther 2014;13(3):585-95
   PubMed Web of Science ®Google Scholar
• Rossato FA, Zecchin KG, La Guardia PG, et al. Fatty acid synthase inhibitors induce apoptosis in non-tumorigenic melan-a cells associated with inhibition of mitochondrial respiration. PLoS ONE 2014;9(6):e101060
   PubMed Web of Science ®Google Scholar
• Bisschop PH, de Metz J, Ackermans MT, et al. Dietary fat content alters insulin-mediated glucose metabolism in healthy men. Am J Clin Nutr 2001;73(3):554-9
   PubMed Web of Science ®Google Scholar
• Djiogue S, Nwabo Kamdje AH, Vecchio L, et al. Insulin resistance and cancer: the role of insulin and IGFs. Endocr Relat Cancer 2013;20(1):R1-17
   PubMed Web of Science ®Google Scholar
• Pollak M. Insulin and insulin-like growth factor signaling in neoplasia. Nature Reviews Cancer 2008;8(12):915-28
   PubMed Web of Science ®Google Scholar
• Thomsen WJ, Grottick AJ, Menzaghi F, et al. Lorcaserin, a novel selective human 5-hydroxytryptamine2C agonist: in vitro and in vivo pharmacological characterization. J Pharmacol Exp Ther 2008;325(2):577-87
   PubMed Web of Science ®Google Scholar
• Higgins GA, Sellers EM, Fletcher PJ. From obesity to substance abuse: therapeutic opportunities for 5-HT2c receptor agonists. Trends Pharmacol Sci 2013;34(10):560-70
   PubMed Web of Science ®Google Scholar
• Halford JCG, Boyland EJ, Lawton CL, et al. Serotonergic anti-obesity agents: past experience and future prospects. Drugs 2011;71(17):2247-55
   PubMed Web of Science ®Google Scholar
• Blundell JE. Serotonin and appetite. Neuropharmacology 1984;23(12B):1537-51
   Google Scholar
• Bello NT, Liang NC. The use of serotonergic drugs to treat obesity–is there any hope? Drug Des Devel Ther 2011;5:95-109
   PubMed Web of Science ®Google Scholar
• Levistsky DA, Troiano R. Metabolic consequences of fenfluramine for the control of body weight. Am J Clin Nutr 1992;55(S1):S167-72
   Google Scholar
• Meltzer HY, Roth BY. Lorcaserin and pimavanserin: emerging selectivity of serotonin receptor subtype – targeted drugs. J Clin Invest 2013;123(12):4986-91
   PubMed Web of Science ®Google Scholar
• Gardin JM, Schumacher D, Constantine G, et al. Valvular abnormalities and cardiovascular status following exposure to dexfenfluramine or phentermine/fenfluramine. JAMA 2000;283(13):1703-9
   PubMed Web of Science ®Google Scholar
• Connolly HM, Crary JL, McGoon MD. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med 1997;337(9):581-8
   PubMed Web of Science ®Google Scholar
• Roth BL. Drugs and valvular heart disease. N Engl J Med 2007;356(1):6-9
   PubMed Web of Science ®Google Scholar
• Martin CK, Redman LM, Zhang J, et al. Lorcaserin, a 5-HT(2C) receptor agonist, reduces body weight by decreasing energy intake without influencing energy expenditure. J Clin Endocrinol Metab 2011;96(3):837-45
   PubMed Web of Science ®Google Scholar
• Smith SR, Prosser W, Donahue D, et al. APD356-004 study group. lorcaserin (APD356), a selective 5-HT2C agonist, safely indices weight loss in 12-week study of healthy obese patients. Presented at: American Diabetes Association 66th Annual Scientific Sessions; 6 December 2006; Washington DC USA
   Google Scholar
• Bays HE. Lorcaserin and adiposopathy: 5HTc agonism as a treatment for “sick fat” and metabolic disease. Expert Rev Cardiovasc Ther 2009;7(11):1429-45
   PubMedGoogle Scholar
• Smith SR, Weissman NJ, Anderson CM. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med 2010;363(3):245-56
   PubMed Web of Science ®Google Scholar
• Fidler MC, Sanchez M, Raether B, et al. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the blossom trial. J Clin Endocr Metab 2011;96(10):3067-77
   PubMed Web of Science ®Google Scholar
• O´Neil PM, Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the Bloom-DM study. obesity (silver spring) 2012;20(7):1426-36
   PubMed Web of Science ®Google Scholar
• Hoy SM. Lorcaserin: a review of its use in chronic weight management. Drugs 2013;73(5):463-73
   PubMed Web of Science ®Google Scholar
• Boyer EW, Shannon M. The serotonin syndrome. N Engl J Med 2005;352(11):1112-20
   PubMed Web of Science ®Google Scholar
• Mason PJ, Morris VA, Balcezak TJ, et al. Serotonin syndrome. Presentation of two cases and review of the literature. Medicine (Baltimore) 2000;79(4):201-9
   PubMed Web of Science ®Google Scholar
• Eisai Inc. BELVIQ (lorcaserin hydrochloride) tablets, for oral use. 2012. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022529lbl.pdf [Accessed 14 August 2014]
   Google Scholar
• Woloshin S, Schwartz LM. The new weight-loss drugs, lorcaserin and phentermine-topiramate: slim pickings? JAMA Intern Med 2014;174(4):615-19
   PubMed Web of Science ®Google Scholar
• Weissman NJ, Sanchez M, Koch G, et al. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of Phase III clinical trials. Circ Cardiovasc Imaging 2013;6(4):560-7
   PubMed Web of Science ®Google Scholar
• Halford JC. Lorcaserin –not a new weapon in the battle with appetite. Nat Rev Endocrinol 2010;6(12):663-4
   PubMed Web of Science ®Google Scholar
• Singh JP, Evans JC, Levy D, et al. Prevalence and clinical determinants of mitral, tricuspid,and aortic regurgitation (the Framingham Heart Study). Am J Cardiol 1999;83(6):897-902
   PubMed Web of Science ®Google Scholar
• Hopkins PN, Polukoff GI. Risk of valvular heart disease associated with use of fenfluramine. BMC Cardiovasc Disord 2003;3:5
   PubMed Web of Science ®Google Scholar
• Jollis JG, Landolfo CK, Kisslo J, et al. Fenfluramine and phentermine and cardiovascular findings: effect of treatment duration on prevalence of valve abnormalities. Circulation 2000;101(17):2071-7
   PubMed Web of Science ®Google Scholar
• Tran P, Thomas A. Summary minutes of the endocrinologic and metabolic drugs advisory committee meeting. 2012. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM303352.pdf [Accessed 12 August 2014]
   Google Scholar
• James WP, Caterson ID, Coutinho W, et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med 2010;363(10):905-17
   PubMed Web of Science ®Google Scholar
• Caterson ID, Finer N, Coutinho W. Maintained intentional weight loss reduces cardiovascular outcomes: results from the sibutramine cardiovascular OUTcomes (SCOUT) trial. Diab Obes Metab 2012;14(6):523-30
   PubMed Web of Science ®Google Scholar
• Clinicaltrial.gov. A study to evaluate the effect of long-term treatment with BELVIQ (Lorcaserin HCl) on the incidence of major adverse cardiovascular events and conversion to type 2 diabetes mellitus in obese and overweight subjects with cardiovascular disease or multiple cardiovascular risk factors (CAMELLIA-TIMI). Accessed 14 August 2014. Available from: http://clinicaltrials.gov/ct2/show/NCT02019264?term=camellia-timi&rank=1
   Google Scholar
• Miller LE. Lorcaserin for weight loss: insights into US FDA approval. J Acad Nutr Diet 2013;113(1):25-30
   PubMed Web of Science ®Google Scholar
• Smith SR, O´Neil PM, Astrup A, et al. Early weight loss while on lorcaserin, diet, and exercise as a predictor of week 52 weight-loss outcomes. Obesity (Silver Spring) 2014;22(10):2137-46
   PubMed Web of Science ®Google Scholar
• Hendricks EJ, Rothman RB, Greenway FL. How physician obesity specialists use drugs to treat obesity. Obesity (Silver Spring) 2009;17(9):1730-5
   PubMed Web of Science ®Google Scholar
• Hampp C, Kang EM, Borders-Hemphil V. Use of prescription antiobesity drugs in the united states. Pharmacotherapy 2013;33(12):1299-307
   PubMed Web of Science ®Google Scholar
• Kye TK, Nadglowski JJr. Drug treatment of obesity. JAMA Intern Med 2014;174(8):1414
   Web of Science ®Google Scholar
• Smith SR. Drug treatment of obesity. JAMA Intern Med 2014;174(8):1414-15
   PubMed Web of Science ®Google Scholar
• Nackers LM, Ross KM, Perri MG. The association between rate of initial weight loss and long-term success in obesity treatment: does slow and steady win the race? Int J Behav Med 2010;17(3):161-7
   PubMed Web of Science ®Google Scholar
• Astrup A, Rössner S. Lessons from obesity management programmes: greater initial weight loss improves long-term maintenance. Obes Rev 2000;1(1):17-19
   PubMedGoogle Scholar
• Scale T, Harvey JN. Diabetes, metformin and lactic acidosis. Clin Endocrinol (Oxf) 2011;74(2):191-6
   PubMed Web of Science ®Google Scholar
• Richy FF, Sabidó-Espin M, Guedes S, et al. Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study. Diabetes Care 2014;37(8):2291-5
   PubMed Web of Science ®Google Scholar